Bacterial Vaginosis and Spontaneous Abortion

细菌性阴道病和自然流产

• 批准号: 7142772
• 负责人: Deborah B Nelson
• 金额: $ 13.83万
• 依托单位: TEMPLE UNIV OF THE COMMONWEALTH
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-06-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7142772
• 关键词: African American; bacterial disease; caucasian American; cervical /vaginal smear; disease /disorder proneness /risk; drug detection; gestational age; human pregnant subject; interview; mass screening; patient oriented research; pregnancy; spontaneous abortion; statistics /biometry; telecommunications; urinalysis; vaginitis; women' s health

DESCRIPTION: Bacterial vaginosis (BV) is extremely prevalent among low-income, urban pregnant women. The current standard of medical care does not involve screening pregnant women for BV unless clinical symptoms are reported; however, the majority of pregnant women with BV are asymptomatic. A number of studies have found associations between BV and late pregnancy outcomes; such as, preterm labor, premature rupture of membrane, chorioamnionitis, and low birth weight. The impact of BV on the risk for spontaneous abortion (SAB) is unclear. In the proposed prospective cohort study, all women will be screened for BV early in pregnancy regardless of symptoms. The specific aims of this study are to: 1) characterize the prevalence and predictors of BV in women early in pregnancy and 2) evaluate whether BV during pregnancy is an important, independent predictor of SAB. Women attending their first clinical prenatal care visit at the Hospital of the University of Pennsylvania Obstetric Clinic with a pregnancy of 12 weeks gestation or less as determined by last menstrual period will be recruited. We will screen all women for bacterial vaginosis and follow-up through 22 weeks gestation to identify women experiencing a spontaneous abortion. We will enroll 2200 women over a three year period arid compare SAB rates for the estimated 400 women found to test positive for BY (20 percent of patients) and the 1600 women found to test negative for By. Baseline data collection will be standardized and include a structured in-person interview, a vaginal smear used to detect By, and urine analysis to determine alcohol, cocaine and cotinine. Follow-up telephone interviews will be conducted at 22 weeks gestation to determine the status of pregnancy (SAB vs. non-SAB) and BV diagnosis and treatment. Pregnancy outcome status will also be ascertained through ongoing review of medical records, pathology logs and birth certificates. Initial analyses will be exploratory and descriptive, characterizing the prevalence and predictors of BV and the risk factors for SAB. The primary analysis will be logistic regression, with relative risks and 95 percent confidence intervals, to explore whether BV is an independent predictor of SAB. This study will provide a unique opportunity to evaluate the prevalence of BV among pregnant women and to determine the relationship between BV and incident SAB.

描述：细菌性阴道病 (BV) 在低收入人群中极为普遍， 城市孕妇。目前的医疗标准不涉及 对孕妇进行细菌性阴道病筛查，除非报告有临床症状；然而， 大多数患有 BV 的孕妇没有症状。多项研究 发现 BV 与晚期妊娠结局之间存在关联；例如， 早产、胎膜早破、绒毛膜羊膜炎和低产 重量。 BV 对自然流产 (SAB) 风险的影响尚不清楚。 在拟议的前瞻性队列研究中，所有女性都将接受 BV 筛查 怀孕初期，无论症状如何。本研究的具体目的是 目的：1) 描述女性早期 BV 的患病率和预测因素 怀孕和 2) 评估怀孕期间 BV 是否重要， SAB 的独立预测因子。参加第一次临床产前检查的女性 宾夕法尼亚大学医院产科诊所护理访问 根据末次月经确定怀孕时间为 12 周或以下 期间将被招募。我们将对所有女性进行细菌性阴道病筛查 妊娠 22 周期间的随访，以确定女性是否经历过 自然流产。我们将在三年内招收 2200 名女性 比较大约 400 名 BY 检测呈阳性的女性的 SAB 率（20 % 的患者）以及 1600 名 By 检测呈阴性的女性。基线 数据收集将标准化，并包括结构化的面对面 面谈、阴道涂片检查和尿液分析来确定 酒精、可卡因和可替宁。后续将进行电话采访 妊娠 22 周时确定妊娠状态（SAB 与非 SAB） 和 BV 诊断和治疗。妊娠结果状态也将是 通过持续审查医疗记录、病理日志和出生来确定 证书。初步分析将是探索性和描述性的， 描述 BV 的患病率和预测因素以及 BV 的危险因素 SAB。主要分析将是逻辑回归，具有相对风险和 95% 置信区间，探讨 BV 是否独立 SAB 的预测因子。这项研究将提供一个独特的机会来评估 孕妇 BV 患病率并确定两者之间的关系 BV 和事件 SAB。